Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

Periodontitis Clinical Trial

Official title:

Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518747
• Other study ID #: UCPH_01_007
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

Description:

The present study is a double-blinded randomized clinical trial with a duration of 12 weeks

. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.

Clinical measurements and sampling will be performed at baseline, week 6 and week 12.

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Periodontitis stage 2-3, Grade B-C, generalized

Exclusion Criteria:

• • Use of systemic antibiotics within the latest three months.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Dietary Supplement:
• Probiotic
In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.
• Placebo
In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Odontology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in microbial composition in dental plaque	Changes in alpha and beta diversity of microbial composition	Baseline vs. week 6 and week 12
Secondary	Changes in dental plaque	Changes in mean level of dental plaque	Baseline vs. week 6 and week 12
Secondary	Changes in bleeding on probing	Changes in mean level of bleeding on probing	Baseline vs. week 6 and week 12
Secondary	Changes in probing pocket depth	Changes in mean level of probing pocket depth	Baseline vs. week 6 and week 12
Secondary	Changes in clinical attachment level	Changes in mean level of clinical attachment level	Baseline vs. week 6 and week 12
Secondary	Changes in salivary levels of inflammatory cytokines	Changes in mean salivary levels of selected inflammatory cytokines	Baseline vs. week 6 and week 12